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Part Used : น้ำจากผลActivity : DRUG INTERACTIONSolvent/Active Compound : orange juiceType of experiment : humanType of animal : -Type of study : Open trialN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: Athough no confidence interval range is set for tmax values, the same calculations noted an effect (183.0% [120.7%, 245.3%]) if one were to reference the guidelines for AUC and Cmax. When taken with nonfortified orange juice, similar changes were seen, but these changes were approximately 50% to 67% smaller than those seen with the calcium-fortified juice, and none of them approached significance in their differences. In terms of bioavailability, no effect was demonstrated between the nonfortified juice and water for any of the tested parameters that have breakpoint guidelines (Cmax, 94.8% [82.6%, 107.0%]: ACU, 94.6% [88.0%, 101.2%]).
Part Used : น้ำจากผลActivity : DRUG INTERACTIONSolvent/Active Compound : orange juiceType of experiment : humanType of animal : -Type of study : Cross overN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: Athough no confidence interval range is set for tmax values, the same calculations noted an effect (183.0% [120.7%, 245.3%]) if one were to reference the guidelines for AUC and Cmax. When taken with nonfortified orange juice, similar changes were seen, but these changes were approximately 50% to 67% smaller than those seen with the calcium-fortified juice, and none of them approached significance in their differences. In terms of bioavailability, no effect was demonstrated between the nonfortified juice and water for any of the tested parameters that have breakpoint guidelines (Cmax, 94.8% [82.6%, 107.0%]: ACU, 94.6% [88.0%, 101.2%]).
Part Used : น้ำจากผลActivity : DRUG INTERACTIONSolvent/Active Compound : calcium-fortified orange juiceType of experiment : humanType of animal : -Type of study : Open trialN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available calcium-fortified orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: A significant increases in total oral clearance (15%) and volume of distribution (13%) along with a matching significant decrease (12%) in exposure (AUC) when gatifloxacin was taken with the fortified juice. Although not statistically significant, peak concentrations decreased by 15% and were reached (tmax) approximately 38% later when gatifloxacin was coadministered with the calcium-fortified juice. Bioavailability testing indicated that although the 90% confidence intervals (Cls) for the ratio of the geometric means of the calcium-fortified juice and water arms' AUC stayed within the range of 80% to 125%, those for Cmax did not.
Part Used : น้ำจากผลActivity : DRUG INTERACTIONSolvent/Active Compound : calcium-fortified orange juiceType of experiment : humanType of animal : -Type of study : Cross overN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available calcium-fortified orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: A significant increases in total oral clearance (15%) and volume of distribution (13%) along with a matching significant decrease (12%) in exposure (AUC) when gatifloxacin was taken with the fortified juice. Although not statistically significant, peak concentrations decreased by 15% and were reached (tmax) approximately 38% later when gatifloxacin was coadministered with the calcium-fortified juice. Bioavailability testing indicated that although the 90% confidence intervals (Cls) for the ratio of the geometric means of the calcium-fortified juice and water arms' AUC stayed within the range of 80% to 125%, those for Cmax did not.
